Neurocrine Moves Up Drug Filing

Neurocrine Biosciences ( NBIX) said Monday it plans to resubmit one version of its Indiplon insomnia drug for government review in the second quarter, faster than the company had previously planned.

The decision represents a reversal in strategy, as the San Diego-based company said it wouldn't conduct an extra, optional test of the drug's safety and effectiveness.

Neurocrine made its announcement after markets had closed, sending the stock up $1.14, or 8.9%, to $14.09 in late trading. The stock slipped 15 cents to $12.95 in regular trading.

Neurocrine said it expects the Food and Drug Administration to take six months to review the immediate-release version of the drug. Neurocrine provided no updated information on its plans for an extended-release version.

Indiplon appeared to be a promising insomnia pill that attracted Pfizer ( PFE) as a marketing partner. But Pfizer cancelled its deal in late June, a month after the FDA rejected Neurocrine's application for an extended-release version. Neurocrine said the FDA wanted more clinical trials.

At the same time, the FDA granted conditional approval for the immediate-release version. Those conditions included analyzing old data and conducting a small test on how the drug is absorbed and excreted by the body and how it reacts with certain foods.

After meeting with the FDA, Neurocrine predicted it would resubmit the quick-release application by the second quarter of 2007, but it then pushed the timetable back to the summer of 2008. Even though the FDA didn't want more clinical trials for the quick-release, Neurocrine decided to conduct an extra trial on the drug's safety and ability to help people fall asleep.

On Monday, the company changed its mind. It won't conduct the extra clinical trial. Instead, it will "direct these resources" to preparing the product for launch and to continue evaluating Indiplon "for traditional sleep maintenance."